COST REIMBURSEMENT

RESEARCH CONSORTIUM AGREEMENT

BETWEEN

CASE WESTERN RESERVE UNIVERSITY

AND

[SUB]

UNDER GRANT [AWNO]

THIS AGREEMENT, by and between Case Western Reserve University, hereinafter referred to as "CASE" and [SUB] whose principal place of business is [SubCity], [SubState] hereinafter referred to as “SUBCONTRACTOR”, is for the purpose as hereinafter set forth.

WHEREAS, CASE is the recipient of the following award (hereinafter referred to as “PRIME AWARD” and attached hereto as Exhibit A):

Award Number: [AWNO]

CFDA Number: [CFDANO]

Project Sponsor: [SPONSOR NAME]

Project Title: [TITLE]

CASE Principal Investigator: [CASE PI NAME]

SUBCONTRACTOR Principal Investigator: [SUBCONTRACTOR PI NAME]

And WHEREAS, said PRIME AWARD involves an approved collaborative effort between CASE and SUBCONTRACTOR where SUBCONTRACTOR has agreed to use its personnel, facilities, and reasonable efforts in the performance of the work, THEREFORE, the parties mutually agree as follows:

ARTICLE I. STATEMENT OF WORK

SUBCONTRACTOR shall provide the necessary personnel, facilities, data and materials to perform the services specified in the attached statement of work, marked Exhibit B, which by this reference is incorporated herein.

ARTICLE II. SCHEDULE FOR DELIVERABLE ITEMS OR REPORTS OR BOTH

In connection with and as part of the work to be performed, SUBCONTRACTOR shall submit reports as specified in the Statement of Work attached hereto and as otherwise required by CASE under the terms of the PRIME AWARD.

ARTICLE III. PERIOD OF PERFORMANCE

Performance of this AGREEMENT shall begin [BSD] and shall not extend beyond the estimated completion date of [BED] unless further extended by amendment of this AGREEMENT, which shall be in writing and signed by all parties to this AGREEMENT.


ARTICLE IV. ESTIMATED COST AND PAYMENT

1. The total of this AGREEMENT shall not exceed: $[COST] on a cost reimbursement basis. Reimbursement shall be in accordance with the line item budget approved by CASE and SUBCONTRACTOR attached hereto as Exhibit C.

2.  The total cost budget represents the maximum amount reimbursable under this AGREEMENT without

prior written approval of CASE.

3. SUBCONTRACTOR shall submit itemized invoices to CASE not more frequently than monthly. The final invoice must be submitted no later than 60 days after the completion date. Said invoices must represent actual expenses paid and be certified by an appropriate institutional official. Invoices shall be submitted to:

Dr. [PIFstNm] [PILstNm] Tel: (216) [PIPhone]

Case Western Reserve University Fax: (216) [PIfax]

[PIDept] E-mail address: [PIemail]

10900 Euclid Avenue

[PIAddress2]

Cleveland, OH 44106

4. For the purpose of determining the amount payable to SUBCONTRACTOR under this AGREEMENT, the allowability of costs shall be determined in accordance with NIH Grant Policy Statement, (Revised 12/01/03) ("the NIH Grants Policy Statement"), and the terms of this AGREEMENT.

ARTICLE V. FEDERAL AGENCY AUDIT

Acceptance of AGREEMENT obligates the parties to comply with audit provisions applicable to Federal agency grantees. SUBCONTRACTOR agrees to fulfill all applicable provisions of such audit provisions, including, but not limited to, Office of Management and Budget regulations promulgated in OMB Circular A-133, OMB Circular A-110, P.L. 104-156, Single Audit Act Amendments of 1996 or 45 CFR 74.26(d), as applicable. SUBCONTRACTOR will complete and return Exhibit D "Sub-contractor's Compliance with A-133" to CASE at the time of execution of this Agreement. In the case of non-compliance, SUBCONTRACTOR will provide copies of the audit report, responses to auditor's report, and a plan for corrective action. SUBCONTRACTOR agrees to permit independent auditors to have access to any other records and financial statements as necessary for CASE to comply with regulations applicable to the AGREEMENT and make available to CASE such information and records as CASE may reasonably request to facilitate CASE compliance with said requirements.

ARTICLE VI. PROJECT DIRECTOR (CASE)

The project director representing CASE for the purpose of technical direction of grant performance shall be [PI]. Any changes to the scope of work by the Subcontractor must be approved in writing by Dr. [PILstNm].

ARTICLE VII. PROJECT DIRECTOR (SUBCONTRACTOR)

The project director representing SUBCONTRACTOR for the purpose of technical direction in accordance with Article I, shall be [SUBPI]. A change in the designated project director shall require the prior written approval of CASE.


ARTICLE VIII. SPECIAL PROVISIONS.

1.  The performance of SUBCONTRACTOR under this AGREEMENT shall conform to the requirements of the prime award, the NIH Grants Policy Statement, and the Federal Demonstration Partnership (FDP) General Terms and Conditions, as applicable. If the SUBCONTRACTOR is a non-US Institution, U.S. Government regulations included herein apply only as specified by the NIH Grants Policy Statement and the FDP General Terms and Conditions, as applicable.

2.  SUBCONTRACTOR agrees to maintain books, records, and documents and other evidence pertaining to all costs and expenses incurred and revenues acquired under this AGREEMENT to the extent and in such detail as will properly reflect all costs and expenses of whatever nature for which reimbursement is claimed. The books of account and other records which are applicable to this AGREEMENT shall at all times be available for inspection, review, and audit by CASE to determine proper application and use of all funds paid to or for the account of benefit of SUBCONTRACTOR.

3. This AGREEMENT may not be assigned in whole or in part without the prior written consent of CASE .

4. SUBCONTRACTOR assumes sole responsibility for reimbursement to CASE of a sum of money equivalent to the amount of any expenditures disallowed should DHHS rule through audit exception or other appropriate means that expenditures from funds allocated to SUBCONTRACTOR were not made in compliance with the regulations of DHHS or the provisions of the AGREEMENT.

5. CASE through its authorized representative, has the right, upon reasonable advance notice, at all reasonable times, to inspect or otherwise evaluate the work performed or being performed by SUBCONTRACTOR.

ARTICLE IX. HEALTH AND SAFETY

The SUBCONTRACTOR is responsible for meeting Federal, State, and local health and safety standards and for establishing and implementing necessary measures to minimize their employees' risk of injury or illness in activities related to NIH grants.

ARTICLE X. HUMAN SUBJECTS

The SUBCONTRACTOR agrees to follow Institutional Review Board (IRB) approved protocols, all applicable law, the Belmont Report, and its own ethical standards in the conduct of any human subject research performed under this AGREEMENT. If participants in the human subject research conducted by the SUBCONTRACTOR might be injured as part of the research, the SUBCONTRACTOR agrees to inform the participant that the participant will be responsible to pay for the medical care for research-related injury. Should the SUBCONTRACTOR, through its ongoing monitoring of human subject research or the results of the research, discover findings that could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study (e.g., serious non-compliance), the SUBCONTRACTOR agrees to promptly report these findings to CASE and to the CASE project director. If, in the course of the study or through the results of the research, CASE discovers findings that could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study (e.g., serious non-compliance), CASE agrees to promptly report these findings to the SUBCONTRACTOR and SUBCONTRACTOR project director.

ARTICLE XI. VERTEBRATE ANIMALS

Should warmblooded animals be used in this project, SUBCONTRACTOR will comply with the applicable portions of the Animal Welfare Act (P.L. 99158) and will follow the guidelines prescribed in the Public Health Services Policy on Humane Care and Use of Laboratory Animals.

ARTICLE XII. RECOMBINANT DNA

For all research involving recombinant DNA techniques, the SUBCONTRACTOR agrees to meet the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (the Guidelines) (59 FR 34496, July 5, 1994 or latest revision).

ARTICLE XIII. PATENTS AND INVENTIONS

Patent and invention rights will be in accordance with Government regulations as set forth in 37 CFR 401, as noted in the NIH Grants Policy Statement.

ARTICLE XIV. INTANGIBLE PROPERTY RIGHTS AND PUBLICATION

The SUBCONTRACTOR agrees to acknowledge the support of CASE and/or the NIH awarding unit whenever activities funded in whole or in part by this subcontract are published in any news media. Any survey, questionnaire or publication arising from and supported by this subcontract will include a positive statement clearly setting forth that the contents are in no way the responsibility of the NIH awarding unit. Rights in intangible property will be in accordance with Government regulations as set forth 45 CFR 74.36, and the terms of the award regarding the NIH rights in copyrightable material and the disposition of royalties and other income earned from a Copyrighted work as noted in the NIH Grants Policy Statement.

The results and data developed by this consortium, if jointly developed, will be jointly owned by the parties, and if developed solely by one party, will be owned solely by that party. Each party grants to the other party a non-exclusive, royalty-free license to use the results and data developed solely by each other provided that each party uses such results and data only for its own internal research and educational purposes. The parties agree to negotiate in good faith in the event that either requests a license for commercial purposes.

There will be no restrictions on the joint publications of part or all of the data and/or discoveries made during the research investigation except as they may be necessary to protect confidential information or to file patents. To this end, the Project Director (CASE) will review all publications prior to submission. Any delay will not exceed 90 days for the purpose of filing patents.

ARTICLE XV. TERMINATION

In the event of termination of the PRIME AWARD, this AGREEMENT shall be automatically terminated as of the termination date of the PRIME AWARD. Additionally, either party shall have the right to terminate this AGREEMENT by giving thirty (30) days written notice of intent to terminate. SUBCONTRACTOR will be reimbursed for any noncancelable obligations properly incurred up to the date of notice of termination.

ARTICLE XVI. INCORPORATION OF APPLICABLE PROVISIONS OF THE PRIME AWARD

All applicable provisions of the PRIME AWARD between CASE and NIH, shall be binding upon SUBCONTRACTOR as noted in the NIH Grants Policy Statement.

ARTICLE XVII. PUBLICITY

No publicity matter having or containing any reference to the other party to this Agreement, or in which the name of the other party is mentioned, shall be made use of until written approval has first been obtained by the party making use of the other party's name.

ARTICLE XVIII. CIVIL RIGHTS, AGE DISCRIMINATION AND EQUAL EMPLOYMENT OPPORTUNITY

SUBCONTRACTOR will comply with TITLE VI of the Civil Rights Act of 1964, Executive Order 11246, and the Age Discrimination Act of 1975. SUBCONTRACTOR assures CASE that it has valid Assurances of Compliance with the DHHS for compliance with the Civil Rights Act of 1964 (Form HHS 441) and section 504 of the Rehabilitation Act of 1973, as amended (Form HHS 641).

ARTICLE XIX. SCIENTIFIC MISCONDUCT

Subcontractor hereby certifies that it has established procedures for dealing with and reporting possible misconduct in science as set forth in 42 CFR 93.103. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

ARTICLE XX. CONFLICT OF INTEREST

In accordance with DHHS rule entitled, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 CFR Part 50, Subpart F), SUBCONTRACTOR certifies that it has established Conflict of Interest Policy that complies with all requirements, rules, procedures, and principles of 42 CFR Part 50, Subpart F, incorporated herein by reference. Per this DHHS rule, should SUBCONTRACTOR identify an investigator(s) who has a conflict of interest with the Statement of Work, the SUBCONTRACTOR will notify CASE of said conflict of interest and whether it is being eliminated, reduced or managed within 30 days of it being identified by the SUBCONTRACTOR.

If Subcontractor does not have a Conflict of Interest Policy, it agrees to abide by and comply with all rules, regulations, and procedures of CASE’s Conflict of Interest Policy (http://ora.ra.Case.edu/main_research_compliance_page.htm). Upon written request by CASE, Subcontractor also agrees to furnish a copy of its Conflict of Interest Policy to CASE within 30 days of receipt of request.

ARTICLE XXI. DEBARMENT AND SUSPENSION

SUBCONTRACTOR certifies to the best of its knowledge and belief that it is not presently debarred, suspended, or proposed for debarment or declared ineligible for the awards of consortia, by any Federal Agency, in accordance with the OMB Guidelines (53 FR1916119211).

ARTICLE XXII. CERTIFICATION OF NONDELINQUENCY ON FEDERAL DEBT

SUBCONTRACTOR certifies that it is in compliance with the NonDelinquency on Federal Debt criteria, in accordance with OMB circular A129.

ARTICLE XXIII. CERTIFICATION OF DRUGFREE WORKPLACE

SUBCONTRACTOR certifies that it has implemented an appropriate policy in accordance with the DrugFree Workplace Act of 1988, 45 CFR Part 76, Subpart F.

ARTICLE XXIV. CERTIFICATION REGARDING LOBBYING

SUBCONTRACTOR certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid, by or on the behalf of the SUBCONTRACTOR, to any person for influencing or attempting to influence a Federal officer or Federal employee of any agency in connection with the awarding of any federal award (Section 1352, Title 31, 4.5 Code).


ARTICLE XXV. CLEAN AIR AND WATER

(Applicable only if the award exceeds $100,000 or a facility to be used has been the subject of a conviction under the Clean Air Act or the Federal Water Pollution Control Act, and is listed by EPA, or if the award is not otherwise exempt.)

The recipient agrees as follows:

1) To comply with applicable standards, orders or regulations issued pursuant to the Clean Air Act, as amended (42 USC 7401, et seq.) and of the Federal Water Pollution Control Act (33 USC 1251 et seq.), 2) That no portion of the work under this award will be performed in a facility listed on the Environmental Protection Agency (EPA) List of Violating Facilities on the date that this award was effective unless and until the EPA eliminates the name of the facility or facilities from such listings, 3) To use its best efforts to comply with clean air standards and clean water standards at the facility in which the award is being performed.